Virological failure to raltegravir in Spain: incidence, prevalence and clinical consequences
Por:
Santos, JR, Blanco, JL, Masia, M, Gutierrez, F, Perez-Elias, MJ, Iribarren, JA, Force, L, Antela, A, Knobel, H, Salavert, M, De Quiros, JCLB, Pino, M, Paredes, R and Clotet, B
Publicada:
1 nov 2015
Resumen:
Objectives: The objective of this study was to evaluate the incidence, prevalence and clinical consequences of virological failure (VF) to raltegravir-based regimens in Spain.
Methods: A multicentre, retrospective, observational study was performed in 10 tertiary hospitals (January 2006 to June 2013). The study included HIV-1-infected patients with loss of virological suppression (LVS; two consecutive HIV-1 RNA >= 50 copies/mL) while receiving raltegravir. VF and low-level viraemia (LLV) were defined as two consecutive HIV-1 RNA = 200 copies/mL and 50 to <200 copies/mL, respectively. Integrase strand-transfer inhibitor resistance was investigated at LVS. During the 48 weeks following LVS, recorded data included clinical characteristics, treatment discontinuations, AIDS-associated events and deaths. Effectiveness of therapy following LVS was evaluated by ITT and PP. Multivariate regression was used to assess predictors of efficacy.
Results: Of the 15009 HIV-infected patients in participating centres, 2782 (18.5%) had received raltegravir-based regimens. Of those, 192 (6.9%), 125 (4.5%) and 67 (2.4%) experienced LVS, VF and LLV, respectively. The incidence of VF was 1.8 (95% CI, 1.5-2.1) per 100 patients/year. The prevalence of VF was 4.5% (95% CI, 3.8%-5.3%). Integrase-associated mutations were found in 78.8% of patients with integrase genotyping results available. High-level resistance to dolutegravir was not observed. Salvage therapy failed in 34.1% of patients; progression to AIDS/death occurred in 8.3% during the first year following LVS. The latter was associated with intravenous drug use, time on raltegravir and lower CD4+ count nadir in patients who started raltegravir-based treatments as salvage regimens.
Conclusions: VF with raltegravir is infrequent, but often associated with major clinical complications in treatment-experienced patients.
Filiaciones:
:
Hosp Univ Germans Trias I Pujol, Fundacio Lluita SIDA, Barcelona 08916, Spain
Univ Autonoma Barcelona, E-08193 Barcelona, Spain
Blanco, JL:
Univ Barcelona, Hosp Clin Barcelona, IDIBAPS, Barcelona, Spain
Masia, M:
Elche Univ Gen Hosp, Infect Dis Unit, Elche, Spain
Miguel Hernandez Univ, Elche, Spain
Gutierrez, F:
Elche Univ Gen Hosp, Infect Dis Unit, Elche, Spain
Miguel Hernandez Univ, Elche, Spain
Perez-Elias, MJ:
Hosp Ramon & Cajal, IRYCIS, Infect Dis Unit, E-28034 Madrid, Spain
Iribarren, JA:
Donostia Univ Hosp, Infect Dis Unit, San Sebastian, Spain
Force, L:
Mataro Hosp, Infect Dis Unit, Mataro, Spain
Antela, A:
Univ Hosp, Infect Dis Unit, Santiago De Compostela, Spain
Knobel, H:
IMIM Hosp Mar Res Inst, Hosp Mar, Infect Dis Serv, Barcelona, Spain
Salavert, M:
La Fe Univ, Infect Dis Unit, Valencia, Spain
Polytech Hosp, Valencia, Spain
De Quiros, JCLB:
Gregorio Maranon Univ Hosp, Infect Dis Unit, Madrid, Spain
Pino, M:
IrsiCaixa AIDS Res Inst, Barcelona, Spain
:
Hosp Univ Germans Trias I Pujol, Fundacio Lluita SIDA, Barcelona 08916, Spain
IrsiCaixa AIDS Res Inst, Barcelona, Spain
Univ Vic Univ Cent Catalunya, Vic, Spain
:
Hosp Univ Germans Trias I Pujol, Fundacio Lluita SIDA, Barcelona 08916, Spain
Univ Autonoma Barcelona, E-08193 Barcelona, Spain
IrsiCaixa AIDS Res Inst, Barcelona, Spain
Univ Vic Univ Cent Catalunya, Vic, Spain
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